F43.1
Conditions
Interventions
Group 1: Patients with post-traumatic stress disorder (PTSD) receive a 12-week ketogenic dietary intervention. The intervention consists of a 2-week introductory phase with a gradual dietary transitio
Sponsors
Universität der Bundeswehr München - Institut für Psychologie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Mental capacity to provide informed consent Provides written confirmation of informed consent Verified PTSD diagnosis according to DSM 5-TR or ICD-11 Currently living in Germany High treatment motivation (score > 7/10) Consent to information sharing within study staff (release from medical confidentiality) No medical or psychiatric contraindication
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding Active alcohol or drug misuse BMI < 18.5 Currently medicated with glucocorticoids, lithium, anticonvulsants, hypertension medication, glucose-lowering medications, or SGLT-2 inhibitor medications Diagnosed with type 1 or type 2 diabetes Diagnosed with severely impaired kidney function Diagnosed with ESLD (End Stage Liver Disease) or ESRD (End Stage Renal Disease) Follows a vegan diet History of eating disorders Acute or chronic suicidality Acute or chronic self-injury behavior Acute positive psychotic/manic symptomatology Already following a ketogenic diet within the past 6 weeks. Any change to psychiatric medication regimen in past 6 weeks Severe hypercholesterolemia (may represent genetic metabolic disorder) Porphyria, heart failure, pancreatitis Institutionally dependent individuals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes assess feasibility via recruitment success, adherence to ketogenic intervention, completion of study assessments, and participant retention over the 12-week intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant self-reported feasibility will be assessed at the end of the 12-week intervention using quantitative items (including a global rating on a 0–10 Likert scale with thresholds and standardized questions on acceptability, appropriateness, and feasibility) as well as qualitative open-ended questions on helpful and challenging aspects, barriers, facilitators, suggestions for improvement, and recommendations, with the qualitative data serving to contextualize and enrich the quantitative outcomes. Exploratory endpoints include psychological outcomes such as changes in PTSD symptom severity, general mental health and functioning, as well as daily EMA symptom monitoring and BHB measurements, to investigate temporal associations between ketone levels and symptom fluctuations. Additionally, physiological and metabolic parameters, including inflammatory and mitochondrial markers as well as immunometabolic analyses, are collected to explore pathophysiological mechanisms. | — |
Countries
Germany
Contacts
Public ContactRobin Engelhardt
Universität der Bundeswehr München - Institut für Psychologie
Outcome results
None listed